FDA Device recall Z-0535-2020
FoundationOne CDx test report
- FDA Device
- Class II
- terminated
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class II recall of FoundationOne CDx test report by Foundation Medicine, citing identified potential false positive MSI-H on the test reports provided to the physicians.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0535-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-08 |
| Published | 2019-12-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Foundation Medicine |
| Distribution | GA, IN, MA, NC, OH |
Product
FoundationOne CDx test report
Reason
Identified potential false positive MSI-H on the test reports provided to the physicians.
Identifiers
| code_info | Model/Lot/Serial Number: QRF150009.01 , QRF150228.01 , QRF150108.01 , QRF149795.01, QRF150117.01 , QRF150247.01 , QRF149634.01 , QRF128938.01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0535-2020%22
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